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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01721889
Other study ID # RSA100
Secondary ID
Status Recruiting
Phase N/A
First received October 31, 2012
Last updated June 10, 2013
Start date November 2012
Est. completion date January 2016

Study information

Verified date June 2013
Source OAD Orthopaedics
Contact Marjorie Delaney, APN
Phone 630-225-2554
Email marjorie.delaney@oadortho.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The primary objective of this pilot study is to determine the precision of post-operative radiostereometric measurements for the assessment of lumbar spinal fusion. This study will also determine the potential for RSA as a more precise and accurate means for assessment of lumbar spinal fusion and diagnosis of pseudarthrosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Symptomatic degenerative disc disease of the lumbar spine indication surgical intervention

- Scheduled to undergo lumbar fusion surgery

- Patients between the ages of 18 and 75

- Ability to give informed consent

Exclusion Criteria:

- Pregnant women

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Radiation:
Radiostereometric Analysis
The radiostereometric (RSA) patient exam (flexion and extension RSA images) presents additional radiation exposure to the patient above standard of care (additional radiographs). Assuming 120kV, using three protocols (two loaded and one unloaded) per RSA exam results in a typical effective dose of approximately 2.04mSv per exam(single lumbar spine RSA at 120kV yields 0.68mSv,). HBI recommends using 140kV for lumbar spine RSA and has conducted simulations to estimate the effective dose using higher kV settings. 140kV reduces the effective dose from 0.68mSv per spine RSA to 0.2mSV, resulting in a total effective dose per RSA exam of 0.6mSv. In comparison, the estimated effective dose for a single standard lumbar spine x-ray is 1.2mSv. This additional radiation exposure is considered to be minimal risk in consideration of the number of planar x-rays the patient will undergo as part of standard care, as well as average background radiation received by humans per year (3.1mSv).

Locations

Country Name City State
United States OAD Orthopaedics Warrenville Illinois

Sponsors (3)

Lead Sponsor Collaborator
OAD Orthopaedics Central DuPage Hospital, Halifax Biomedical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intervertebral motion post-op lumbar fusion The purpose of this radiostereometric analysis (RSA) evaluation is to measure relative intervertebral motion in lumbar spinal fusions. Two RSA loading provocation protocols will be employed in this study; sitting and supine extension. Both loading protocols will be compard to a standard supine position which is used as an unloaded baseline protocol. Induced intervetebral motion sets will be calculated between the two loaded states, sitting and supine extension, and the unloaded state. The RSA micromotion results will be calculated and reported as translations and rotations about the three anatomic axes, maximum total point motion (MTPM) will be calculated as well. 2 years No
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